clinical study of r744 to predialysis patients

Conditions: Anemia in Pre-Dialysis Patients

Summary: this study will assess the efficacy and safety of subcutaneous or intravenous r744 in renal anemia patients on predialysis.


Eligibility criteria:
inclusion criteria: * patients whose serum creatinine level has been ≥ 2.0 mg/dl or creatinine clearance has been ≥ 30 ml /min at any one time point within 12 weeks before registration * patients aged ≥ 20 years at the time of obtaining consent * patients who have been receiving a rhuepo preparation at least once a month for at least 8 weeks before registration * patients whose mean value of hb concentrations determined within 8 weeks before registration has been between ≥ 10.0 g/dl and \<13.0 g/dl * patients whose transferrin saturation has been ≥ 20 % or ferritin has been ≥ 100ng/ml at any one time point within 8 weeks before registration exclusion criteria: * patients with hardly controllable hypertension (patients whose diastolic blood pressure has been ≥ 100 mmhg on more than 1/3 of the determining occasions within 12 weeks before registration) * patients with congestive cardiac failure (≥ class iii in nyha cardiac function classification) * female patients who are pregnant, lactating, possibly pregnant or not willing to take a contraceptive measure in the period from the day of starting the treatment with the study drug to 90 days after the day of the last dose of the study drug * patients with complication of myocardial infarction, pulmonary infarction or cerebral infarction (excluding asymptomatic cerebral infarction) * patients who are applicable to the following criteria ⅰ), ⅱ), ⅲ), and whose mean value of hb concentrations determined within 8 weeks before registration has been \> 12.0 g/dl * ⅰ)patients with an anamnesis of myocardial infarction, pulmonary infarction or cerebral infarction (excluding asymptomatic cerebral infarction) * ⅱ)patients with complication of unstable angina pectoris or controlled angina pectoris (hardly controlled regardless of drug treatment or interventional treatment ) * ⅲ)patients with congestive cardiac failure (≥ class ii in fontaine arteriosclerosis obliterans classification) * patients confirmed to have serious allergy or serious drug allergy (shock, anaphylactoid symptom) * patients hypersensitive to a rhuepo preparation * patients with malignant tumor (including hemic malignant tumor), severe infection, systemic hemic disease (osteomyelodysplasia syndrome, hemoglobinopathy, etc.), hemolytic anemia or apparent hemorrhagic lesion such as digestive tract hemorrhage * patients who have received an anabolic hormone preparation, testosterone enanthate or mepitiostane within 12 weeks before registration * patients who have received another investigational drug within 12 weeks before registration * patients who have received r744 before registration * patients whose ast(got) value ≥ 100 iu/l or alt(gpt) value ≥ 100 iu/l before registration * patients who have received erythrocyte transfusion within 16 weeks before registration * patients for whom a surgical operation accompanied by marked bleeding is planned during the study period * in addition, patients who are judged as ineligible to participate in this study by the investigator or sub-investigator